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临床试验/NCT00963391
NCT00963391已完成不适用

"Alcohol Based Hand Sanitizers for the Prevention of Acute Diarrheal Disease and Acute Respiratory Infection in Children Under 5 Attending Childcare Centers in Bogotá, Cundinamarca and Tolima, in Colombia: a Cluster Randomized Control Trial"

Fundación Santa Fe de Bogota1 个研究点 分布在 1 个国家目标入组 1,727 人开始时间: 2008年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,727
试验地点
1
主要终点
Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection

研究概览

简要总结

The purpose of this study is to conduct a Randomized Control Trial (RCT) in a developing country setting in order to evaluate the role of alcohol based hand sanitizers (ABHS) in preventing the transmission of infectious diseases in areas where water is a scarce resource. The investigators want to find out if the use of ABHS reduces the incidence of two leading causes of morbidity and mortality in children under 5 years of age in the developing world: acute diarrheal disease (ADD) and acute respiratory infections (ARI).

详细描述

We performed a cluster, RCT in child care centers located in six urban settings of Colombia with intermittent tap water availability. A total of 1727 children between 1 and 5 years of age distributed in 42 childcare centers participated in the study. The intervention consisted on installation of ABHS gel dispensers and training on their use by participating children in child care centers. Centers assigned to the control group were recommended to continue with current hand hygiene practices. Child care centers matched by location, size and sanitary conditions were randomly assigned to intervention or control. Cases of Acute Diarrheal Disease (ADD) and Acute Respiratory Infections ARI were identified through teacher reported signs and symptoms of disease and validated by a trained physician. We also monitored adverse events potentially related to ABHS. To compare incidence rates between study arms we modeled the number of episodes of ADD and ARI per child using a Cox proportional hazards multiple regression with random effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 1 and 5 years of age
  • Attending child care centers with limited tap water availability

排除标准

  • Chronic conditions
  • Not willing to participate

结局指标

主要结局

Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection

时间窗: April - December 2008

次要结局

  • Number of Adverse Events(April - December 2008)

研究者

发起方
Fundación Santa Fe de Bogota
申办方类型
Other

研究点 (1)

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